Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

• Sponsor: NRG Oncology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03180268
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 148
• Locations: 185
• Arms: 2
• Anticipated Duration (Months): 122.5
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

Condition or Disease	Intervention/Treatment	Phase
Grade II Meningioma; Intracranial Meningioma	Other: Clinical Observation; Radiation: Radiation Therapy	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To determine, in terms of progression-free survival (PFS), the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.

SECONDARY OBJECTIVES:

1. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Outcomes and patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Tissue microarray construction, and assessment of pHH3 mitotic index and molecular correlates to OS.

OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection.

ARM I: Patients undergo observation.

ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each).

After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
• Actual Study Start Date: Jun 14, 2017
• Anticipated Primary Completion Date: Jun 15, 2027
• Anticipated Study Completion Date: Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm I (Clinical Observation) Patients undergo observation after gross total resection.	Other: Clinical Observation; Undergo observation
Experimental: Arm II (Radiation Therapy) Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions after gross total resection.	Radiation: Radiation Therapy; Undergo radiation therapy; Other Names: Cancer Radiotherapy Irradiate Irradiated Irradiation RADIATION Radiotherapeutics Radiotherapy RT Therapy, Radiation

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years.]

   Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in PFS between the two arms (Peto 1972).

Secondary Outcome Measures

1. Overall Survival (OS) [From randomization to death due to any cause, assessed up to 10 years]

   Kaplan-Meier method will be used to calculate the OS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in OS between the two arms (Peto 1972). Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.

2. 5 Year Overall Survival (OS) [At 5 years after randomization]

   Will be calculated based on the Kaplan-Meier curve.

3. Disease-Specific Survival (DSS) [From randomization to disease-related death, assessed up to 10 years]

   Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk (Gray 1988). Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates (Fine 1999).

4. 3 Year Disease-Specific Survival (DSS) [At 3 years after randomization]

   Will be calculated using the cumulative incidence function for each arm.

5. 5 Year Disease-Specific Survival (DSS) [At 5 years after randomization]

   Will be calculated using the cumulative incidence function for each arm.

6. 3 Year Progression-Free Survival (PFS) [From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years after randomization.]

   Will be calculated based on the Kaplan-Meier curve.

7. 5 Year Progression-Free Survival (PFS) [From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years after randomization.]

   Will be calculated based on the Kaplan-Meier curve.

8. Neurocognitive Function (NCF) [Baseline up to 60 months after randomization]

   Longitudinal analysis will be performed to compare NCF over time between the 2 arms, using the NCF Clinical Trial Battery (CTB) composite score. Early change from baseline in CTB composite score will be evaluated and compared between the 2 arms using 2-sample t tests.

9. Patient Reported Outcomes (PRO) as assessed by MDASI-BT [Baseline up to 60 months after randomization]

   Longitudinal analysis will be performed to compare symptom burden over time between the 2 arms, using the MDASI-BT. Early change from baseline in symptom burden will be evaluated and compared between the 2 arms using 2-sample t tests.

10. Assessment of pHH3 mitotic index [Up to 10 years after randomization]

    The Kaplan-Meier method will be used to estimate the PFS and OS rates by pHH3 category. The HRs on the effect of pHH3 on PFS and OS, respectively will be calculated using the Cox proportional hazard model and will be tested using the log-rank test. Multivariate analyses will be conducted with patient pretreatment characteristics, such as age and Simpson resection grade, included as covariates.

11. Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia) [Up to 3 years after randomization]

    The number of adverse events will be measured using the CTCAE, version 4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• PRIOR TO STEP 1 REGISTRATION:

• The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution; WHO grade will be assigned according to WHO 2016 criteria

• Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings

• Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection

• For step 1 registration the operating neurosurgeon must provide the modified Simpson grade

• GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

• If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study

• NOTE: Central pathology review must occur between steps 1 and 2 of registration; once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization

• PRIOR TO STEP 2 REGISTRATION:

• Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration

• History/physical examination, including neurologic examination within 60 days prior to step 2 registration

• Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration

• If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception

Exclusion Criteria:

• Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma

• Definitive evidence of metastatic meningioma

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)

• Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas

• Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:

• Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration

• Transmural myocardial infarction within the last 6 months prior to step 2 registration

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration

• Type II neurofibromatosis (NF2)

• Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration

• Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia

• Pregnancy and/or nursing females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35233
2	Saint Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
3	Mayo Clinic Hospital in Arizona	Phoenix	Arizona	United States	85054
4	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
5	University of Arizona Cancer Center-Orange Grove Campus	Tucson	Arizona	United States	85704
6	Banner University Medical Center - Tucson	Tucson	Arizona	United States	85719
7	University of Arizona Cancer Center-North Campus	Tucson	Arizona	United States	85719
8	Kaiser Permanente-Anaheim	Anaheim	California	United States	92806
9	Sutter Cancer Centers Radiation Oncology Services-Auburn	Auburn	California	United States	95603
10	Kaiser Permanente Dublin	Dublin	California	United States	94568
11	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
12	Los Angeles County-USC Medical Center	Los Angeles	California	United States	90033
13	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
14	Memorial Medical Center	Modesto	California	United States	95355
15	Kaiser Permanente Oakland-Broadway	Oakland	California	United States	94611
16	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
17	Stanford Cancer Institute Palo Alto	Palo Alto	California	United States	94304
18	Kaiser Permanente-Rancho Cordova Cancer Center	Rancho Cordova	California	United States	95670
19	Rohnert Park Cancer Center	Rohnert Park	California	United States	94928
20	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California	United States	95661
21	The Permanente Medical Group-Roseville Radiation Oncology	Roseville	California	United States	95678
22	Sutter Medical Center Sacramento	Sacramento	California	United States	95816
23	South Sacramento Cancer Center	Sacramento	California	United States	95823
24	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
25	Kaiser Permanente Cancer Treatment Center	South San Francisco	California	United States	94080
26	Sutter Solano Medical Center/Cancer Center	Vallejo	California	United States	94589
27	Hartford Hospital	Hartford	Connecticut	United States	06102
28	Yale University	New Haven	Connecticut	United States	06520
29	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
30	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
31	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
32	TidalHealth Nanticoke / Allen Cancer Center	Seaford	Delaware	United States	19973
33	Boca Raton Regional Hospital	Boca Raton	Florida	United States	33486
34	UM Sylvester Comprehensive Cancer Center at Coral Gables	Coral Gables	Florida	United States	33146
35	UM Sylvester Comprehensive Cancer Center at Deerfield Beach	Deerfield Beach	Florida	United States	33442
36	Baptist MD Anderson Cancer Center	Jacksonville	Florida	United States	32207
37	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	United States	33136
38	Miami Cancer Institute	Miami	Florida	United States	33176
39	AdventHealth Orlando	Orlando	Florida	United States	32803
40	AdventHealth East Orlando	Orlando	Florida	United States	32822
41	Moffitt Cancer Center	Tampa	Florida	United States	33612
42	Grady Health System	Atlanta	Georgia	United States	30303
43	Emory Proton Therapy Center	Atlanta	Georgia	United States	30308
44	Piedmont Hospital	Atlanta	Georgia	United States	30309
45	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	United States	30322
46	Emory Saint Joseph's Hospital	Atlanta	Georgia	United States	30342
47	Northside Hospital	Atlanta	Georgia	United States	30342
48	Northside Hospital-Forsyth	Cumming	Georgia	United States	30041
49	Piedmont Fayette Hospital	Fayetteville	Georgia	United States	30214
50	Piedmont Newnan Hospital	Newnan	Georgia	United States	30265
51	Piedmont Henry Hospital	Stockbridge	Georgia	United States	30281
52	Queen's Medical Center	Honolulu	Hawaii	United States	96813
53	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
54	Northwestern University	Chicago	Illinois	United States	60611
55	Rush University Medical Center	Chicago	Illinois	United States	60612
56	University of Illinois	Chicago	Illinois	United States	60612
57	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
58	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois	United States	60201
59	Northwestern Medicine Cancer Center Delnor	Geneva	Illinois	United States	60134
60	NorthShore University HealthSystem-Glenbrook Hospital	Glenview	Illinois	United States	60026
61	NorthShore University HealthSystem-Highland Park Hospital	Highland Park	Illinois	United States	60035
62	Loyola University Medical Center	Maywood	Illinois	United States	60153
63	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois	United States	60555
64	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
65	IU Health Methodist Hospital	Indianapolis	Indiana	United States	46202
66	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
67	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
68	University of Kansas Cancer Center	Kansas City	Kansas	United States	66160
69	University of Kansas Cancer Center-Overland Park	Overland Park	Kansas	United States	66210
70	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
71	MaineHealth Coastal Cancer Treatment Center	Bath	Maine	United States	04530
72	Maine Medical Center-Bramhall Campus	Portland	Maine	United States	04102
73	MaineHealth Cancer Care Center of York County	Sanford	Maine	United States	04073
74	Maine Medical Center- Scarborough Campus	Scarborough	Maine	United States	04074
75	Maryland Proton Treatment Center	Baltimore	Maryland	United States	21201
76	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
77	Tufts Medical Center	Boston	Massachusetts	United States	02111
78	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
79	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
80	Saint Joseph Mercy Chelsea	Chelsea	Michigan	United States	48118
81	Henry Ford Macomb Hospital-Clinton Township	Clinton Township	Michigan	United States	48038
82	Henry Ford Hospital	Detroit	Michigan	United States	48202
83	Ascension Saint John Hospital	Detroit	Michigan	United States	48236
84	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
85	Ascension Saint Mary's Hospital	Saginaw	Michigan	United States	48601
86	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
87	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan	United States	48322
88	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
89	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
90	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
91	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
92	Regions Hospital	Saint Paul	Minnesota	United States	55101
93	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
94	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
95	Siteman Cancer Center at West County Hospital	Creve Coeur	Missouri	United States	63141
96	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
97	Siteman Cancer Center-South County	Saint Louis	Missouri	United States	63129
98	Siteman Cancer Center at Saint Peters Hospital	Saint Peters	Missouri	United States	63376
99	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
100	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
101	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
102	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
103	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
104	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
105	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
106	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
107	Rutgers New Jersey Medical School	Newark	New Jersey	United States	07101
108	Capital Health Medical Center-Hopewell	Pennington	New Jersey	United States	08534
109	ProCure Proton Therapy Center-Somerset	Somerset	New Jersey	United States	08873
110	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States	08876
111	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
112	New York-Presbyterian/Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
113	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
114	The New York Hospital Medical Center of Queens	Flushing	New York	United States	11355
115	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
116	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
117	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
118	NYP/Weill Cornell Medical Center	New York	New York	United States	10065
119	University of Rochester	Rochester	New York	United States	14642
120	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553
121	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599
122	Case Western Reserve University	Cleveland	Ohio	United States	44106
123	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
124	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
125	Mercy Cancer Center-Elyria	Elyria	Ohio	United States	44035
126	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio	United States	44060
127	ProMedica Flower Hospital	Sylvania	Ohio	United States	43560
128	UHHS-Westlake Medical Center	Westlake	Ohio	United States	44145
129	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
130	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
131	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon	United States	97210
132	Saint Luke's University Hospital-Bethlehem Campus	Bethlehem	Pennsylvania	United States	18015
133	Christiana Care Health System-Concord Health Center	Chadds Ford	Pennsylvania	United States	19317
134	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
135	Geisinger Medical Oncology-Lewisburg	Lewisburg	Pennsylvania	United States	17837
136	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
137	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
138	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
139	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
140	Geisinger Cancer Services-Pottsville	Pottsville	Pennsylvania	United States	17901
141	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
142	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
143	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
144	Medical University of South Carolina	Charleston	South Carolina	United States	29425
145	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
146	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
147	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
148	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
149	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	United States	37232
150	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	United States	75390
151	M D Anderson Cancer Center	Houston	Texas	United States	77030
152	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
153	American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	United States	84003
154	Intermountain Medical Center	Murray	Utah	United States	84107
155	Utah Valley Regional Medical Center	Provo	Utah	United States	84604
156	Riverton Hospital	Riverton	Utah	United States	84065
157	LDS Hospital	Salt Lake City	Utah	United States	84143
158	Norris Cotton Cancer Center-North	Saint Johnsbury	Vermont	United States	05819
159	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
160	University of Washington Medical Center - Montlake	Seattle	Washington	United States	98195
161	Legacy Salmon Creek Hospital	Vancouver	Washington	United States	98686
162	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
163	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
164	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
165	Froedtert Menomonee Falls Hospital	Menomonee Falls	Wisconsin	United States	53051
166	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
167	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
168	Marshfield Clinic Stevens Point Center	Stevens Point	Wisconsin	United States	54482
169	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
170	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
171	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
172	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8V 5C2
173	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
174	University Health Network-Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
175	CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2X 3E4
176	The Research Institute of the McGill University Health Centre (MUHC)	Montreal	Quebec	Canada	H3H 2R9
177	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
178	Tata Memorial Hospital	Mumbai		India	400 012
179	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
180	Iwate Medical University Hospital	Shiwa-gun	Iwate	Japan	028-3695
181	Keio University	Shinjuku-ku	Tokyo	Japan	160-8582
182	Hiroshima University Hospital	Hiroshima City		Japan	734-8551
183	Saitama Medical University International Medical Center	Saitama		Japan	350-1298
184	National Cancer Center Hospital	Tokyo		Japan	104 0045
185	King Faisal Specialist Hospital and Research Centre	Riyadh		Saudi Arabia	11211

Sponsors and Collaborators

• NRG Oncology
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: C. Leland Rogers, MD, NRG Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NRG Oncology
• ClinicalTrials.gov Identifier: NCT03180268
• Other Study ID Numbers: NRG-BN003; NCI-2016-01619; NRG-BN003; NRG-BN003; NRG-BN003; U10CA180868
• First Posted: Jun 8, 2017
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Meningioma

Study Results

No Results Posted as of Jan 18, 2022